Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 216184
Company: ZYDUS LIFESCIENCES

Products on ANDA 216184

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDOMETHACIN	INDOMETHACIN	50MG	SUPPOSITORY;RECTAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216184

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/02/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 216184

INDOMETHACIN

SUPPOSITORY;RECTAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INDOMETHACIN	INDOMETHACIN	50MG	SUPPOSITORY;RECTAL	Prescription	No	AB	215399	AMNEAL
INDOMETHACIN	INDOMETHACIN	50MG	SUPPOSITORY;RECTAL	Prescription	No	AB	216905	ANNORA PHARMA
INDOMETHACIN	INDOMETHACIN	50MG	SUPPOSITORY;RECTAL	Prescription	No	AB	073314	COSETTE
INDOMETHACIN	INDOMETHACIN	50MG	SUPPOSITORY;RECTAL	Prescription	No	AB	215899	HIKMA
INDOMETHACIN	INDOMETHACIN	50MG	SUPPOSITORY;RECTAL	Prescription	No	AB	216184	ZYDUS LIFESCIENCES